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Spinal Fixation System

by Canwell Medical Co., Ltd

510(k) K161151

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161151↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK161151 Date21 Sep 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MNH
FDA applicant
Canwell Medical Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a spinal fixation system, classified under orthopedic implants designed to stabilize the spine through surgical intervention. It provides rigid support to the vertebral column, aiding in the treatment of spinal deformities, fractures, or degenerative conditions by maintaining proper alignment and promoting healing through internal fixation components such as screws, rods, and connectors.

The system is intended for surgical use in controlled clinical settings, such as operating rooms, and is supplied sterile for single-use. It is regulated under the FDA’s 510(k) pathway with a clearance type designated as Traditional, falling under the product code MNH. Authorized by both FDA 510K and MDR compliance, it adheres to strict manufacturing and safety standards for spinal orthopedic devices.

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